Manufacturers’ Network · 2019. 6. 15. · already “engaged” by DVMN 14 2 funding calls – Oct 2018 and Feb 2019 (up to $50,000) for consultancy support for developing country

Developing Countries’ Vaccine Manufacturers’ Network

International

Improving vaccination for all people

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Mission: our purpose and mandate

• To protect all people against known and emerging infectious diseases, by improving the availability of high-quality vaccines globally.

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DCVMN International

• It is a voluntary, non-governmental, non-partisan, not-for-profit, public health driven alliance of vaccine manufacturers, research and policy organizations from all over the world.

• Operates based on principles of international scientific, technical and economic cooperation.


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Developing Countries Economies

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transitioning to developed economy

developing economies according to the UN & IMF

https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdf

http://en.wikipedia.org/wiki/File:Developing_countries_map.pnghttp://en.wikipedia.org/wiki/Developed_economyhttps://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdfhttps://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdfhttps://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdfhttps://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdfhttps://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/WESP2019_BOOK-web.pdf

DCVMN 2019: 44 manufacturers from 14 countries/territories

Latin America

Middle East Africa Asia Pacific 10‘772

4‘412

52‘872 60‘802

11‘217

Members as of January 2019 Members with WHO PQ vaccines 5

number of birth cohorts 2015 regionally are indicated in black (x1000) http://www.who.int/immunization/monitoring_surveillance/data/en/

http://www.who.int/immunization/monitoring_surveillance/data/en/

Our Challenge : vaccination to all people Our Chance: partnerships

CONFIDENTIAL - DRAFT - FOR INTERNAL USE ONLY

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The developing world needs more vaccines

https://www.gatesnotes.com/2017-Annual-Letter

1980 Smallpox Eradication

4 billion

Gavi, DCVMN, GF EVI, IVI, IVR, MMV, UNAIDS, STOP TB…

1988: Polio Eradication

penicillin in 1928

https://www.gatesnotes.com/2017-Annual-Letterhttps://www.gatesnotes.com/2017-Annual-Letterhttps://www.gatesnotes.com/2017-Annual-Letterhttps://www.gatesnotes.com/2017-Annual-Letterhttps://www.gatesnotes.com/2017-Annual-Letter

DCVMN Contributions to the Global Vaccination Landscape

Tetanus elimination

Initiatives 2019-2021 to Support DCVMs

Our main 3 goals are to: A) build technical capabilities and strengthen capacity of MFs to produce and deliver quality

vaccines across the long-term, B) proactively engage DCVMN members on priority issues shaping the broader landscape (e.g.,

regulatory knowledge, supply chain, etc.) and C) establish more systematic & proactive dialogue with international bodies to shape DCVM

issues. Interviews and extensive discussions were conducted with members and 6 initiatives were recommended: 1. Training: Expand current QMS programs to include training on GMP, GCP, GLP, GDP, PV,

etc. 2. Best-practice sharing: foster peer to peer communication through expert working groups 3. Advance regulatory convergence: support efforts to new approaches on a regional basis 4. Increase access to international expert consultants for needed ad hoc support 5. Engage MFs on new technology adoption through AGM 6. Support for pharmacovigilance (PV) projects to enhance vaccines safety monitoring


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1. Teach to Reach


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1. Training: Expand current QMS programs to include training on GMP, GCP, GLP, GDP, PV, and other issues


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Immersive learning: investing in people to create innovative mindset & enablement prior to “hands on”


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3 «hands-on» main scenarios where VR training can impact operational capacity: 1. Equipment operation 2. Emergency management 3. Laboratory (testing/formulation)

https://drive.google.com/file/d/1xeF3Lm8rNgeU0YFH6hE3NExnDOIkxvxF/view

VR hands on training Training Chain: relay training

Focus on QC assays to improve technology /methodology, reducing risks and inspections

Support QC Team training in a expert QC lab (NIBSC/ISS/ etc.) for new testing assays: One “trainee” at a time (2-4 weeks), on a relay setting to

build strong teams (3-5 people). Next trainee comes only when the previous returned and passed on the knowledge

Enables common understanding of the whole process and team building and 3Rs, and sustainability

https://drive.google.com/file/d/1xeF3Lm8rNgeU0YFH6hE3NExnDOIkxvxF/view

2. Expert Networking

• Enhance best-practice sharing, and peer to peer communications through expert working groups and hands-on training, as possible

– Supply-chain experts working group

– Vaccine Safety best-practices

– QC assays & technologies

– Formulation & filling expertise

– Etc…

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3. Foster dialogue to advance regulatory

convergence approaches

Challenges to registrations were identified by an independent expert consultant and discussed with members

Create consensus among manufacturers from both DCVMN-IFPMA on key points for dialogue before communicating with NRAs

Two papers published, increasing awareness of challenges and solutions

Supporting regulatory open discussions at stakeholder meetings, as for example:

AVAREF, ICDRA, ASEAN, PANDHR, CoRE

Study on changes/variations to improve vaccines’ access

3Rs: innovative assays to reduce animal use

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https://www.ncbi.nlm.nih.gov/pubmed/29724510

In press

https://www.ncbi.nlm.nih.gov/pubmed/29724510

4. Access to International Experts • DCVMN’s Consultants Portal at

www.dcvmn.org • Consultants register themselves in

the DCVMN database – Centralized pool of expertise – Transparency on qualifications – Consultants based in 22 countries – Declared availability to DCVMN and to Members – Not working for other manufacturers and

“moonlighting”

• > 100 registered consultants; ca. 50% already “engaged” by DCVMN

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2 funding calls – Oct 2018 and Feb 2019 (up to $50,000) for consultancy support for developing country members of DCVMN. FVMR Hub awarded $90,000 to two such members (one manufacturer in China and another in India). Next call in ~Oct 2019.

• How to ensure calls meet needs of manufacturers

• How to improve the quality of the application

• How to grow enduring partnerships

http://www.dcvmn.org/

5. Engage members on innovative technologies adoption


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30th October 2018, AGM, Bill Gates: “looking forward to the partnerships we can have over the next decade” https://www.dcvmn.org/IMG/pdf/bill_gates_kunming_video_news.pdf

https://www.dcvmn.org/IMG/pdf/bill_gates_kunming_video_news.pdf

6. Pharmacovigilance (PV) to improving vaccines safety monitoring


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Number of DCVMs PQed vaccines over 25 years: DCVMN works

17 (*Sanofi = 30; GSK = 17; Seqirus = 6; MSD = 4; J&J = 2; Pfizer = 2, among others MFs) https://extranet.who.int/gavi/PQ_Web/

Manufacturer/Year 1993 1995 1996 1997 1999 2000 2001 2003 2004 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 PQ vaccines Manufacturer

Bharat/India 1 2 1 4 Bharat

BioE/India 1 1 2 1 2 1 1 9 BioE

BioM/Brazil 1 1 2 BioM

Cadila HC 1 1

CNBG/China 1 1 2 CNBG

EuBiologics/Korea 1 1 2 EuBiologics

GreenCross/Korea 1 1 1 1 1 5 GreenCross

Green Signal/India 1 1 GreenSignal

Haffkine/India 1 1 1 3 Haffkine

LG Chem/Korea 1 1 1 3 LGChem

Panacea/India 1 1 2 Panacea

Biofarma/Indonesia 2 2 1 1 2 1 1 1 1 1 1 14 Biofarma

Serum Institute/India 1 3 1 2 1 2 1 3 1 1 2 1 1 2 22 Serum Institute of India

Sinovac/China 1 1 Sinovac

SK Biosciences 1 1Total 15 1 3 1 2 2 1 2 3 3 4 1 1 3 6 3 5 4 5 5 4 7 6 2 72 from ca. 146 Total

# PQ vaccines 10 23 41

# PQed vaccines # MFs with PQ

https://extranet.who.int/gavi/PQ_Web/

Memberships and Strong Partnerships towards building healthy countries


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Credit: http://www.vibincblog.com/?tag=partnership

“Coming together is a beginning;

keeping together is progress;

working together is success.”

http://www.vibincblog.com/?tag=partnershiphttp://www.vibincblog.com/?tag=partnership

3Rs

• Reliable: – able to be trusted; consistently good in quality or

performance: «yes means yes, no means no» attitude

• Responsive:

– responding readily and with interest or enthusiasm: «answer to queries, emails, reports, etc.» attitude

• Responsible:

– be answerable for one's actions; having control over or accountable for something, as part of one's job/ role.

– “Yes, I do” , “yes, I can” , “yes, I will” attitude

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DCVMN Collaborating organizations and Partners


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http://www.gea.com/http://www.biozeen.com/https://www.gavi.org/http://en.wikipedia.org/wiki/PATH_(global_health_organization)http://www.rommelag.com/

DCVMN International

www.dcvmn.org

Individually we are one drop, together we are an ocean Ryunosuke Satoro
http://www.dcvmn.org/

Documents

Manufacturers’ Network · 2019. 6. 15. · already “engaged” by DVMN 14 2 funding calls – Oct 2018 and Feb 2019 (up to $50,000) for consultancy support for developing country